SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM— 510(k) K993335

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K993335 for SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM, Substantially Equivalent on 2000-06-12. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 1999-10-04
Decision date: 2000-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.